Anastomosis devices

ABSTRACT

Implantable medical devices for connecting tissue layers or occluding body conduits and tissue structures include apposition portions, a central region, and a covering material. The methods of using the devices include endoscopic deployment, and the devices may include self-expanding frameworks that facilitate a secure connection between the tissue structures. In some embodiments, one or more tethers are used to longitudinally contract the device in situ.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation U.S. patent application Ser. No.15969038, filed May 2, 2018, which is a continuation of U.S. patentapplication Ser. No. 14/700,480, filed Apr. 30, 2015, now U.S. Pat. No.10,004,509, issued Jun. 26, 2018, which claims the benefit of U.S.Provisional Application 61/987,954, filed May 2, 2014, which areincorporated herein by reference in their entireties for all purposes.

FIELD

The present disclosure relates to implantable medical devices, and morespecifically, to implantable devices for connecting tissue layers tocreate an anastomosis.

BACKGROUND

An anastomosis is a cross-connection between two tissue structures, suchas blood vessels or intestines. For example, in the context of coronaryartery bypass graft surgery, a graft vessel is anastomosed to a nativecoronary artery so that blood can flow through the graft vessel.

Anastomoses can be created in various manners including, but not limitedto: end-to-end, end-to-side, and side-to-side anastomoses. Often,suturing is used to create such anastomoses.

SUMMARY

A first aspect of the invention relates to an implantable medical devicethat includes (1) a first apposition portion having a plurality of firstapposition members, (2) a second apposition portion having a pluralityof second apposition members, and (3) a central portion having at leastone supported region and at least one unsupported region. The supportedregion includes a frame member and the unsupported region includes acovering material. The central portion interconnects the first andsecond apposition portions and is selectively longitudinallycontractible. In some embodiments, the first apposition portion and thesupported region includes a first elongate member and the secondapposition portion includes a second elongate member. The unsupportedregion may consist of the cover material. In some embodiments, the firstelongate member has a first stiffness and/or a first geometry and thesecond elongate member has a second stiffness and/or a second geometrythat is different than the first stiffness and/or first geometry,respectively. In at least one embodiment, the first apposition portion,the supported region, and the second apposition member is formed of asingle elongate member. The device may also include a tether affixed toone of the first apposition portion and the second apposition portion.The device may further include at least one locking member. In someembodiments, the collapsible central portion includes an unsupportedregion positioned between a first supported region and a secondsupported region.

A second aspect of the invention relates to an implantable medicaldevice that includes (1) a first apposition portion, (2) a secondapposition portion, (3) a collapsible central portion interconnectingthe first and second apposition members, and (4) a tether to collapsethe central portion. The device optionally includes at least one lockingmember. The central portion has therein at least one unsupported regionthat includes a cover material. In at least one exemplary embodiment,the first apposition portion includes a first elongate member and thesecond apposition portion includes a second elongate member. The firstelongate member may have a first geometry and/or first stiffness and thesecond elongate member has a second geometry and/or second stiffnessthat is different than the first geometry and/or second stiffness. Inaddition, the first apposition portion and the second apposition portionmay be formed of a single elongate member.

A third aspect of the invention relates to a method for creating ananastomosis that includes (1) positioning a medical device in anundeployed configuration such that the medical device spans a first bodypart and a second body part and (2) providing a hollow conduittherebetween. The implantable medical device includes (1) a firstapposition portion, (2) a second apposition portion, (3) a collapsiblecentral portion having at least one supported region and an unsupportedregion, and (4) a tether affixed to one of the first apposition portionand the second apposition portion. Optionally, the device furtherincludes at least one locking member. The central portion interconnectsthe first and second apposition portions. Also, the supported regionincludes a frame member and the unsupported region includes a coveringmaterial. The method further includes applying a force to the tether todraw the first apposition portion and the second apposition portiontowards each other and collapse the central portion to place the medicaldevice in a deployed configuration, the deployed configuration having ashortened length relative to the undeployed configuration.

DESCRIPTION OF DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of the disclosure and are incorporated in and constitute apart of this specification, illustrate embodiments, and together withthe description serve to explain the principles of the disclosure.

FIG. 1 is a cutaway perspective view of an exemplary stent device thathas been implanted within a patient to act as a shunt between thepatient's gallbladder and intestine in accordance with some embodiments;

FIG. 2 is a side view an exemplary anastomosis device in accordance withsome embodiments;

FIG. 3 is a perspective view of the anastomosis device of FIG. 2 shownin a longitudinally contracted configuration;

FIG. 4 is a side view of the anastomosis device of FIG. 2 shown in alongitudinally contracted configuration; and

FIGS. 5-8 are a series of schematic illustrations showing the deploymentprocess of the anastomosis device of FIG. 2.

DETAILED DESCRIPTION

Persons skilled in the art will readily appreciate that various aspectsof the present disclosure can be realized by any number of methods andapparatus configured to perform the intended functions. It should alsobe noted that the accompanying drawing figures referred to herein arenot necessarily drawn to scale, but may be exaggerated to illustratevarious aspects of the present disclosure, and in that regard, thedrawing figures should not be construed as limiting.

The present disclosure is directed to implantable devices for connectingtissue layers, for example, to circumvent a conduit or organ blockage,such as by creating a direct passage between tissue structures (e.g.connecting a gallbladder and a portion of a gastrointestinal tract) tocreate an anastomosis that facilitates material flow therebetween. Thedevices described herein are endoscopically deployable or deliverablevia a catheter and may include self-expanding apposition mechanisms thatfacilitate a secure connection between the tissue structures (such aconnection may also be referred to herein as a “shunt,” “passageway,”“shunt passageway,” or “tunnel”). Such design features simplifyimplantation and reduce the likelihood of complications. In someembodiments, the devices provided herein are configured to be removableafter implantation. As one example, the device is implanted and remainsin place until the gallbladder and/or its associated ducts are clearedof blockages, after which the device is removed. In another example, thedevice remains implanted until the body grows a tissue-anastomosisaround the device, and then the device is removed. In other embodiments,tissue ingrowth into and/or around the device permanently implants thedevice, and the device is not removed. The devices described herein canprovide alternative treatments for patients who are not suitablecandidates for other types of treatments (e.g., gallbladder removalsurgery) and/or to avoid known complications of other types oftreatments (e.g., external biliary drainage).

This disclosure refers to anastomosis devices in an exemplary fashion.That is, it should be understood that the inventive concepts disclosedin this disclosure can also be applied to other types of devices. Forexample, this disclosure also provides implantable devices that, in someembodiments, can be used for occluding tissue structures, organs, bodyconduits, blood vessels, the GI tract, and the like. For example, insome embodiments the devices provided herein can be used to occludeseptal defects. In some embodiments, the devices provided herein can beused to occlude a patient's vasculature or GI tract. In some suchembodiments, the device does not include a tunnel or central aperturethrough the device. Rather, in some embodiments a covering materialseals the device to inhibit, modulate, or substantially prevent materialfrom flowing through the device.

Referring to FIG. 1, an exemplary anastomosis device 40 in accordancewith some embodiments provided herein that can be implanted in a patientto create a fluidic connection between two organs, spaces, tissuestructures, conduits, and the like, and combinations thereof isdepicted. For example, in the depicted implementation the anastomosisdevice 40 is connecting a gallbladder 10 (that defines an internalgallbladder space 12) with an intestine 20 (that defines an internalintestinal space 22). Hence, the anastomosis device 40 is acting as afluidic shunt device between the internal gallbladder space 12 and theinternal intestinal space 22. Such an implementation may provide abeneficial treatment to the patient when, for example, a flow blockageexists in the native anatomical conduits connecting the internalgallbladder space 12 and the internal intestinal space 22. For example,in some instances the patient may have one or more gallstones that causea blockage of the patient's cystic duct 14 and/or common bile duct 16.In such a case, the anastomosis device 40 can provide a fluidicpassageway such that bile from the gallbladder 10 can flow into theintestine 20. If not for the anastomosis device 40, when bile is blockedfrom flowing out of the gallbladder 10 cholecystitis (inflammation ofthe gallbladder 10) may result.

While the anastomosis devices provided herein can be used in someimplementations to relieve or prevent cholecystitis as described above,it should be understood that the anastomosis devices provided herein canalso be used in many other types of implementations within a patient.For example, the anastomosis devices provided herein can be used inconjunction with various body tissue structures and organs such as, butnot limited to, stomachs, colons, small intestines, pancreases, bloodvessels, bladders, kidneys, conduits, and the like.

In general, some embodiments of the anastomosis devices provided herein(of which anastomosis device 40 is one type of example), include a firsttissue apposition portion 42 a, a second tissue apposition portion 42 b,and a central portion 44 therebetween. The central portion 44 defines alumen 46 that extends longitudinally from a first end of the anastomosisdevice 40 to a second end of the device 40. The lumen 46 acts as aconnection (e.g., a shunt, or passageway) between the internalgallbladder space 12 and the internal intestinal space 22, such that theinternal gallbladder space 12 is in fluid communication with theinternal intestinal space 22 via the anastomosis device 40. The lumen 46has a radial (circular) rigidity by which the anastomosis device 40remains patent.

It should be understood that one or more design features of theanastomosis devices provided herein can be combined with one or moreother features of other anastomosis devices provided herein. In effect,hybrid designs that combine various features from two or more of theanastomosis device designs provided herein can be created, and areconsidered to be within the scope of this disclosure.

Referring to FIGS. 2-4, an exemplary anastomosis device 800 includes aframework of one or more elongate elements 808 that defines a firstapposition portion 802, a second apposition portion 804, and a centralportion 806. The anastomosis device 800 defines a longitudinal axis 801.The central portion 806 is disposed between and interconnects the firstapposition portion 802 and the second apposition portion 804. In someembodiments, a covering material 812 is disposed on at least someportions of the framework.

The example anastomosis device 800 also includes a first tether 810 a, asecond tether 810 b, and a third tether 810 c. As described furtherbelow, in some embodiments the tethers 810 a, 810 b, and 810 c are usedto longitudinally contract the anastomosis device 800 in situ. While thedepicted embodiment includes three tethers 810 a, 810 b, and 810 c, insome embodiments less than three or more than three tethers areincluded. For example, in some embodiments one tether, two tethers, ormore than three tethers are included.

In some embodiments, a covering material 812 is disposed on at leastsome portions of the anastomosis device 800. As described further below,the covering material 812 can be disposed on some portions or on all ofthe first apposition portion 802, the second apposition portion 804,and/or the central portion 806. In some embodiments, portions of thefirst apposition portion 802, the second apposition portion 804, and/orthe central portion 806 can remain free of the covering material 812.

In some embodiments, the central portion 806 defines a lumen 807 thatextends between the first apposition portion 802 and the secondapposition portion 804. In some implementations, the lumen 807 providesa passageway through which biological materials or liquids can pass. Theanastomosis device 800 is shown in an expanded configuration (alsoreferred to herein as a deployed configuration). The expanded ordeployed configuration is the configuration that the device 800naturally exhibits in the absence of external forces acting upon thedevice 800 (e.g., the forces from being radially constrained in adelivery lumen). In should be understood that when the anastomosisdevice 800 is implanted in a patient, the configuration of the device800 may be somewhat different than shown because of the external forcesfrom the patient's anatomy that are exerted on the device 800.

In some embodiments, the framework of the anastomosis device 800, asdescribed further below, can be made of a variety of metallic shapememory materials and/or super-elastic alloys. Thus, in some embodimentsthe central portion 806 (and/or the apposition portions 802 and 804) canbe configured to self-expand to the deployed configuration. In someembodiments, the central portion 806 is balloon expandable to thedeployed configuration, or supplemental expansion forces can be appliedto a self-expandable device by balloon dilation. The diameter of thecentral portion 806 can be made in any size as desired in order to suitthe intended use and/or delivery system of the anastomosis device 800.

When the anastomosis device 800 is configured in its expanded deployedconfiguration as shown, the diameter of the central portion 806increases to a deployed diameter. The diameter of the central portion806 can be made in any dimension as desired in order to suit theintended use and/or delivery system of the anastomosis device 800. Insome implementations, the deployed outer diameter of the central portion806 is configured to at least partially anchor the device 800 via aninterference fit with the tissue aperture in which the central portion806 resides. However, in some implementations the deployed outerdiameter of the central portion 806 is slightly less than the diameterof the tissue aperture in which the central portion 806 resides, and theapposition portions 802 and 804 compress the tissue to provide themigration resistance. In some embodiments, the fully expanded diameterof the central portion 806 is about 30 mm, or about 25 mm, or about 20mm, or about 15 mm, or about 12 mm, or about 10 mm, or about 8 mm, orabout 6 mm, or about 4 mm, and the like. In some embodiments, the fullyexpanded diameter of the central portion 806 is in a range between about20 mm to about 30 mm, or about 15 mm to about 25 mm, or about 10 mm toabout 20 mm, or about 5 mm to about 15 mm, or about 4 mm to about 8 mm,and the like.

The length of the central portion 806 can be made in any dimension asdesired in order to suit the intended use and/or delivery system of theanastomosis device 800. For instance, in one exemplary embodiment thefully longitudinally expanded central portion 806 is about 50 mm inlength. In some embodiments, the length of the central portion 806 canbe in a range from about 40 mm to about 70 mm, or about 30 mm to about60 mm, or about 20 mm to about 50 mm, or about 10 mm to about 40 mm, orabout 20 mm to about 40 mm.

In some embodiments, the anastomosis device 800 has a framework thatcomprises one or more elongate elements 808. In some embodiments, theone or more elongate elements 808 are wound into the frameworkconfiguration. In some embodiments, a single elongate element 808 iswound to form the framework of the anastomosis device 800. In someembodiments, two or more elongate elements 808 are cooperatively woundto form the framework of the anastomosis device 800.

In some embodiments, the framework of the first apposition portion 802,the second apposition portion 804, and the central portion 806 areformed of one or more elongate elements 808 made of materials such as,but not limited to, spring wire (e.g., L605 steel or stainless steels),shape memory alloy wire (e.g., nitinol or nitinol alloys), super-elasticalloy wire (e.g., nitinol or nitinol alloys), other suitable types ofelongate elements or wires, or combinations thereof. In someembodiments, the first apposition portion 802, the second appositionportion 804, and the central portion 806 are formed from a precursormaterial that is cut to create the framework of elongate elements 808.In some such embodiments, the precursor material is a single piece ofprecursor material. In some embodiments, one or more elongate elements808 are wound into a configuration to form the framework. In someembodiments, different types of elongate elements 808 are used atdifferent locations of the first apposition portion 802, the secondapposition portion 804, and/or the central portion 806. In someembodiments, the elongate elements 808 of the first apposition portion802, the second apposition portion 804, and/or the central portion 806(or portions thereof) may be constructed of polymeric materials.

Suitable materials for the elongate elements 808 of the anastomosisdevice 800 and/or other devices provided herein include a variety ofmetallic materials including alloys exhibiting, shape memory, elasticand super-elastic characteristics. Shape memory refers to the ability ofa material to revert to an originally memorized shape after plasticdeformation by heating above a critical temperature. Elasticity is theability of a material to deform under load and return (or substantiallyreturn) to its original shape when the load is released. Most metalswill deform elastically up to a small amount of strain. Super-elasticityrefers to the ability of a material to deform under strain to muchlarger degree than typical elastic alloys, without having thisdeformation become permanent. For example, the super-elastic materialsincluded in the frames of some anastomosis device embodiments providedherein are able to withstand a significant amount of bending and flexingand then return to or substantially to the frame's original form withoutdeformation. In some embodiments, suitable elastic materials includevarious stainless steels which have been physically, chemically, andotherwise treated to produce a high springiness, metal alloys such ascobalt chrome alloys (e.g., ELGILOY™, MP35N, L605), platinum/tungstenalloys. Embodiments of shape memory and super-elastic alloys include theNiTi alloys, ternary shape memory alloys such as NiTiPt, NiTiCo, NiTiCr,or other shape memory alloys such as copper-based shape memory alloys.Additional materials could combine both shape memory and elastic alloyssuch as drawn filled tube where the outer layer is constructed ofnitinol and the inner core is a radiopaque material such as platinum ortantalum. In this construct, the outer layer provides the super-elasticproperties and the inner core remains elastic due to lower bendingstresses.

In some embodiments, the elongate elements 808 used to construct theanastomosis device 800 and/or other devices provided herein can betreated in various ways to increase the radiopacity of the devices forenhanced radiographic visualization. In some embodiments, the devicesare least partially a drawn-filled type of NiTi containing a differentmaterial at the core, such as a material with enhanced radiopacity. Insome embodiments, the devices include a radiopaque cladding or platingon at least portions of the first apposition portion, the secondapposition portion, and the central portion. In some embodiments, one ormore radiopaque markers are attached to the devices. In someembodiments, the elongate elements and/or other portions of the devicesprovided herein are also visible via ultrasound, and may includeportions with enhanced echogenicity.

In some embodiments, the materials and configuration of the anastomosisdevice 800 (and the other anastomosis device embodiments providedherein) allow the devices to be elastically crushed, folded, and/orcollapsed into a low-profile delivery configuration for containmentwithin a lumen for transcatheter or endoscopic/thorascopic delivery, andto self-expand to an operative size and configuration once positioned ata desired target site within a body and deployed from the lumen. Forexample, in the low-profile delivery configuration the anastomosisdevice 800 can be disposed within a delivery sheath that has about a 15Fr. (5 mm) outer diameter. However, in some embodiments, sheaths thatare smaller or larger than 15 Fr. can be used. For example, sheaths thathave outer diameters of 6 Fr., 7 Fr., 8 Fr., 9 Fr., 10 Fr., 11 Fr., 12Fr., 13 Fr., 14 Fr., 16 Fr., 17 Fr., 18 Fr., 19 Fr., 20 Fr., and largerthan 20 Fr., can be used in some embodiments. While the anastomosisdevice 800 is configured in a collapsed delivery configuration, in someembodiments the framework of one or more elongate elements 808 isradially compressed such that the elongate elements 808 are forced toextend substantially parallel to axis of the central portion 806, andthe diameter of the central portion 806 is crushed to become smaller.

The anastomosis device 800 also includes the covering material 812(which may also be referred to herein as a “covering”). In someembodiments, the covering material 812 is disposed on at least someportions (or on all) of the first apposition portion 802, the secondapposition portion 804, and the central portion 806. In someembodiments, some portions of the first apposition portion 802, thesecond apposition portion 804, and/or the central portion 806 are notcovered by the covering material 812.

In some embodiments, the covering material 812 is generally fluidimpermeable. That is, in some embodiments the covering material 812 ismade of a material that inhibits or reduces passage of blood, bileand/or other bodily fluids and materials through the covering material812 itself. In some embodiments, the covering material 812 has amaterial composition and configuration that inhibits or prevents tissueingrowth and/or endothelialization or epithelialization into thecovering material 812. Some such embodiments that are configured toinhibit or prevent tissue ingrowth and/or endothelialization can be morereadily removed from the patient at a future date if so desired. In someembodiments, the covering material 812, or portions thereof, has amicroporous structure that provides a tissue ingrowth scaffold fordurable sealing and/or supplemental anchoring strength of theanastomosis device 800.

In some embodiments, the covering material 812 comprises afluoropolymer, such as an expanded polytetrafluoroethylene (ePTFE)polymer, or polyvinylidene fluoride (PVDF). In some embodiments, thecovering material 812 comprises a polyester, a silicone, a urethane,biocompatible polymer(s), polyethylene terephthalate (e.g., Dacron®),bioabsorbable materials, copolymers, or combinations thereof. In someembodiments, the covering material 812 comprises a bioabsorbable web. Inother embodiments, the bioabsorbable material may also provide ananti-migration feature by promoting attachment between the device 800and tissue until the bioabsorbable material is absorbed.

In some embodiments, the covering material 812 (or portions thereof) ismodified by one or more chemical or physical processes that enhance oneor more properties of the material 812. For example, in someembodiments, a hydrophilic coating may be applied to the coveringmaterial 812 to improve the wettability and echo translucency of thematerial 812. In some embodiments, the covering material 812, orportions thereof, may be modified with chemical moieties that facilitateone or more of endothelial cell attachment, endothelial cell migration,endothelial cell proliferation, and resistance to or promotion ofthrombosis. In some embodiments, the covering material 812, or portionsthereof, may be modified to resist biofouling. In some embodiments, thecovering material 812, or portions thereof, may be modified with one ormore covalently attached drug substances (e.g., heparin, antibiotics,and the like) or impregnated with the one or more drug substances. Thedrug substances can be released in situ to promote healing, reducetissue inflammation, reduce or inhibit infections, and to promotevarious other therapeutic treatments and outcomes. In some embodiments,the drug substance may be, but is not limited to a corticosteroid, ahuman growth factor, an anti-mitotic agent, an antithrombotic agent, astem cell material, or dexamethasone sodium phosphate. In someembodiments, a pharmacological agent is delivered separately from thecovering material 812 to the target site to promote tissue healing ortissue growth.

Coatings and treatments may be applied to the covering material 812before or after the covering material 812 is joined or disposed on oraround the framework of the anastomosis device 800. Additionally, one orboth sides of the covering material 812, or portions thereof, may becoated. In some embodiments, certain coatings and/or treatments areapplied to the covering material(s) 812 located on some portions of theanastomosis device 800, and other coatings and/or treatments are appliedto the material(s) 812 located on other portions of the anastomosisdevice 800. In some embodiments, a combination of multiple coatingsand/or treatments are applied to the covering material 812, or portionsthereof. In some embodiments, certain portions of the covering material812 are left uncoated and/or untreated. In some embodiments, the device800 is fully or partially coated to facilitate or frustrate a biologicalreaction, such as, but not limited to, endothelial cell attachment,endothelial cell migration, endothelial cell proliferation, andresistance to or promotion of thrombosis.

In some embodiments, a first portion of the covering material 812 isformed of a first material and a second portion of the covering material812 is formed of a second material that is different than the firstmaterial. In some embodiments, the covering material 812 is comprised ofmultiple layers of materials, which may be the same or differentmaterials. In some embodiments, portions of the covering material 812have one or more radiopaque markers attached thereto to enhance in vivoradiographic visualization of the anastomosis device 800, or one or moreechogenic areas to enhance ultrasonic visibility.

In some embodiments, one or more portions of the covering material 812are attached to the framework of the device 800, such as the centralportion 806 and/or the apposition portions 802 and 804. The attachmentcan be accomplished by a variety of techniques such as, but not limitedto, stitching the covering material 812 to the framework of the device800, adhering the covering material 812 to the framework of the device800, laminating multiple layers of the covering material 812 toencompass portions of the elongate members of the device 800, usingclips or barbs, laminating multiple layers of the covering materialtogether through openings in the framework of the device 800. In someembodiments, the covering material 812 is attached to the framework ofthe device 800 at a series of discrete locations, thereby facilitatingthe flexibility of the framework. In some embodiments, the coveringmaterial 812 is loosely attached to the framework of the device 800. Itis to be appreciated that the covering material 812 may be attached tothe framework using other techniques or combinations of techniquesdescribed herein.

In some embodiments, the framework of the device 800 (or portionsthereof) is coated with a bonding agent (e.g., fluorinated ethylenepropylene (FEP) or other suitable adhesive) to facilitate attachment ofthe covering material 812 to the framework. Such adhesives may beapplied to the framework using contact coating, powder coating, dipcoating, spray coating, or any other appropriate means.

In some embodiments, the covering material 812 can adapt to changes inthe length and/or diameter of the central portion 806 in a variety ofmanners. In a first example, the covering material 812 can be elasticsuch that the covering material 812 can stretch to accommodate changesin the length and/or diameter of the device 800. In a second example,the covering material can include slackened material in the low-profiledelivery configuration that becomes less slackened or totallyunslackened when the device 800 is in the expanded configuration. In athird example, the covering material 812 can include folded portions(e.g., pleats) that are folded in the low-profile configuration and lessfolded or totally unfolded when the device 800 is in the expandedconfiguration. In some embodiments, combinations of such techniques,and/or other techniques can be used whereby the covering material 812can adapt to changes in the length and/or diameter of the centralportion 806.

The one or more elongate element(s) 808 of the central portion 806 canbe configured in various ways to define a generally cylindricalframework. In the embodiment depicted in FIG. 2, the elongate element(s)808 of the central portion 806 are wound circumferentially around thecentral portion 806. In addition to the circumferential winding, theelongate element(s) 808 can exhibit other winding paths, such as thewavy or serpentine path shown (e.g., approximately sinusoidal) and otherpaths. In the depicted embodiment, the winding path of the elongateelement(s) 808 in the central portion 806 has about eight apices percircumference. In some embodiments, the elongate element(s) 808 of thecentral portion 806 can be made to have more or less than eight apicesper circumference. For example, in some embodiments the elongateelement(s) 808 of the central portion 806 can be made to have three,four, five, six, seven, nine, ten, eleven, twelve, thirteen, fourteen,fifteen, sixteen, or more than sixteen apices per circumference.

It should be understood that, while the anastomosis device 800 is in theexpanded configuration, the anastomosis device 800 may be selectivelyadjusted to a desired longitudinal length by manipulation of the tethers810 a, 810 b, and 810 c. For example, FIG. 2 shows the anastomosisdevice 800 configured to have its maximum longitudinal length. Incontrast, FIGS. 3 and 4 show the anastomosis device 800 configured tohave a shorter longitudinal length. The shorter longitudinal length ofthe anastomosis device 800 is attained by pulling tethers 810 a, 810 b,and 810 c proximally, to thereby longitudinally compress (contract) thecentral portion 806. Hence, the central portion 806 of the anastomosisdevice 800 can be characterized as being selectively longitudinallycontractible. In some embodiments, the tethers 810 a, 810 b, and 810 cwill lock in their positions such that the longitudinally contractedarrangement of the anastomosis device 800 will be retained.

In some embodiments, the anastomosis device 800 includes a singleelongate element 808. That is, in some embodiments a single continuouselongate element 808 forms the framework of each of the first appositionportion 802, the second apposition portion 804, and the central portion806.

In some embodiments, the anastomosis device 800 includes two elongateelements 808. That is, in some embodiments two elongate elements 808 areused to form the framework of the first apposition portion 802, thesecond apposition portion 804, and the central portion 806. For example,in some embodiments a first elongate element 808 may form the frameworkof just the first apposition portion 802, and a second elongate element808 may form the framework of both of the second apposition portion 804and the central portion 806. In another example, a first elongateelement 808 may form the framework of both of the first appositionportion 802 and the central portion 806, and a second elongate element808 may form the framework of just the second apposition portion 804.

In some embodiments, the anastomosis device 800 includes three elongateelements 808. That is, in some embodiments a first continuous elongateelement 808 forms the framework of the first apposition portion 802, asecond elongate element 808 forms the framework of the second appositionportion 804, and a third elongate element 808 forms the framework of thecentral portion 806. Such a configuration may provide some advantages.For example, having a separate elongate element 808 in the centralportion 806 may allow for a smaller low-profile delivery configuration.In addition, a separate elongate element 808 in the central portion 806may allow for more conformability to tissue topography and allow thecentral axis 801 to bend to accommodate organ locations and/orperistalsis, generally independent of the first and second appositionportions 802 and 804.

In some embodiments, the anastomosis device 800 includes more than threeelongate elements 808. In some embodiments, one or both of the firstapposition portion 802 and/or the second apposition portion 804 can becomprised of more than one elongate elements 808.

In some embodiments that include two or more elongate elements 808, theelongate elements 808 may have differing properties, such as, but notlimited to, diameters, stiffnesses, material compositions, shape-memoryproperties, cross-sectional shapes, geometries, elasticities, and thelike.

The anastomosis device 800 includes the first apposition portion 802 andthe second apposition portion 804. In some embodiments, theconfigurations (geometries) of the apposition portions 802 and 804 aresubstantially the same. In some embodiments, the configurations of theapposition portions 802 and 804 are different from each other. Forexample, in some embodiments the first apposition portion 802 may havemultiple apposition members 803 (refer to FIG. 3), while the secondapposition portion 804 may have more, fewer, or no apposition members803. In another example, in some embodiments the first appositionportion 802 may have multiple apposition members 803 shaped generally asshown, while the second apposition portion 804 may have multipleapposition members that are shaped differently. All such combinationsand permutations are envisioned, and within the scope of thisdisclosure.

In some embodiments, such as the depicted embodiment, the elongateelement 808 of the central portion 806 is configured in a sinusoidalpattern that is wrapped helically around the longitudinal axis 801 alongthe central portion 806. In some embodiments, a majority of the centralportion 806 is unsupported by the elongate element 808 of the centralportion 806. In some embodiments, one or more elongate elements 808 maybe configured in any other suitable arrangement in the central portion806.

In some embodiments, the central portion 806 includes one or moresupported regions and one or more unsupported regions. The one or moresupported regions are the regions of the central portion 806 where theelongate element 808 is disposed. The one or more unsupported regionsare the regions of the central portion 806 where no elongate element 808is disposed (hence the covering material 812 is unsupported by theelongate element 808 in the unsupported regions).

The anastomosis device 800 includes the tethers 810 a, 810 b, and 810 c.In some embodiments the tethers 810 a, 810 b, and 810 c are used tolongitudinally contract the anastomosis device 800 in situ. That is, bypulling on tethers 810 a, 810 b, and 810 c, a clinician canlongitudinally shorten the central portion 806 of the anastomosis device800. In some embodiments, the tethers 810 a, 810 b, and 810 c aredisposed in a range from about 100° to about 140° apart from each other,or in a range from about 110° to about 130° apart from each other, or atabout 120° apart from each other around the periphery of the anastomosisdevice 800. In some embodiments, other relative arrangements between thetethers 810 a, 810 b, and 810 c are used. While in the depictedembodiment, the anastomosis device 800 includes three tethers 810 a, 810b, and 810 c, in some embodiments one, two, four, five, six, seven,eight, nine, ten, or more than ten tethers are included.

In some embodiments, the tethers 810 a, 810 b, and 810 c are made ofmaterials such as, but not limited to, PTFE (polytetrafluoroethylene),nylon, and the like, and combinations thereof. In some embodiments, thetethers 810 a, 810 b, and 810 c are monofilaments. In some embodiments,the tethers 810 a, 810 b, and 810 c are multifilament constructs such asbraided or twisted constructs. In some embodiments, it is advantageousfor the tethers 810 a, 810 b, and 810 c to have low elasticity toprovide a clinician with precision control of the application ofcontraction forces to the central portion 806.

In some embodiments, the paths of the tethers 810 a, 810 b, and 810 care generally as follows. The first ends of the tethers 810 a, 810 b,and 810 c are located proximally and exterior to the patient such thatthe clinician can apply tension to the tethers 810 a, 810 b, and 810 c.From the proximal ends, the tethers 810 a, 810 b, and 810 c extendtowards the anastomosis device 800 (e.g., through one or more lumens ofa catheter). As shown, the tethers 810 a, 810 b, and 810 c pass througha proximal end (e.g., near apposition portion 804) of the anastomosisdevice 800 and extend to a distal end (e.g., near apposition portion802) of the anastomosis device 800. At the distal end of the anastomosisdevice 800, the tethers 810 a, 810 b, and 810 c are routed through oraround a structure of the anastomosis device (e.g., the elongate element808 or covering material 812) and then back towards the proximal end ofthe anastomosis device 800. The second ends of the tethers 810 a, 810 b,and 810 c are tied or otherwise affixed to a structure of theanastomosis device 800 at the proximal end of the anastomosis device800. As a result of being routed in this fashion, when a clinician pullsor applies tension to one or more of the tethers 810 a, 810 b, and 810c, the central portion 106 of the anastomosis device 800 will belongitudinally compressed.

In some embodiments, locking members are included such that the tethers810 a, 810 b, and 810 c remain detained (locked) in a tensioned stateafter the clinician has induced a desired amount of shortening to thecentral portion 806 by pulling on the tethers 810 a, 810 b, and 810 c.

The anastomosis device 800 can advantageously be used to adapt to arange of tissue thicknesses. Accordingly, the size selection of theanastomosis device 800 for a particular target location is simplified.In the example deployment process depicted in FIGS. 5-8, the anastomosisdevice 800 is being used to create an anastomosis between two tissuewalls 50 and 60.

Referring to FIG. 5, a deployment catheter 900 that has been navigatedto an opening between the two tissue walls 50 and 60 is shown. Thedeployment catheter 900 contains the anastomosis device 800 in aradially compressed low-profile delivery configuration. In someimplementations, the deployment catheter 900 has been navigated to theopening via an endoscope working channel.

Referring to FIG. 6, the anastomosis device 800 has been deployed fromthe deployment catheter 900. The anastomosis device 800 has beendeployed such that the first apposition portion 802 and the secondapposition portion 804 are on opposite sides of the double tissue walls50 and 60. In some embodiments, the deployment comprises removing anouter containment member from the anastomosis device 800 (such as apolymeric sleeve that can be “unzipped”). In some embodiments, thedeployment comprises pushing the anastomosis device 800 out of a lumen.In some embodiments, the deployment comprises pulling back a deliverysheath so that the anastomosis device emerges from a lumen of thedelivery sheath.

Initially after deployment from the deployment catheter 900, theanastomosis device 800 is radially expanded and longitudinally expanded.Radially, the anastomosis device 800 conforms to the opening or near tothe opening of the tissues 50 and 60. Longitudinally, the anastomosisdevice 800 is in its full length arrangement.

Referring to FIG. 7, a clinician user can apply tension to the tethers810 a, 810 b, and 810 c to longitudinally shorten (contract) theanastomosis device 800. In doing so, the first apposition portion 802and the second apposition portion 804 can come into contact with thetissue walls 60 and 50 respectively. In some implementations, thecontraction of the anastomosis device 800 may also force the tissuewalls 50 and 60 closer together, or into contact with each other.

Referring to FIG. 8, the deployment catheter 900 can be withdrawn. Insome implementations, the tethers 810 a, 810 b, and 810 c are leftattached to the anastomosis device 800 as shown. In someimplementations, the tethers 810 a, 810 b, and 810 c are left attachedto the anastomosis device 800 but the tethers 810 a, 810 b, and 810 care trimmed in length. The tethers 810 a, 810 b, and 810 c may be usedlater to assist with removal of the anastomosis device 800 in somecases.

The anastomosis devices provided herein are deployable to a target sitewithin a patient using one or more catheters, delivery sheaths, andother suitable devices and techniques. In some implementations, theanastomosis devices provided herein are deployable using an endoscopicor laparoscopic approach.

In some embodiments the devices provided herein can be used for sealingor anchoring a heart valve implant. A heart valve implant enablesone-way flow of blood from a heart chamber and usually has a firstinflow end and a second outflow end. The contractions of the heart causeflow of blood through the valve from the inflow end to the outflow end.Between the inflow and outflow ends, a valve assembly within the heartvalve implant provides for one way flow, opening to allow flow from theinflow to the outflow end when the pressure of the blood is higher onthe inflow end, and closing to prevent flow when the pressure on theoutflow end is higher than the inflow end. In some embodiments, thedevice includes a tunnel or central aperture through the device withapposition portions to anchor a valve assembly and seal against backwardflow. A valve assembly can be attached in the tunnel or centralaperture. The apposition portions of the device can be configured to behighly conformable to the topography of the heart chambers or bloodvessels, and compliant with the beating movements of the heart. In someembodiments, a covering material is configured to allow flow through avalve assembly in the tunnel or aperture while preventing flow aroundthe apposition portions.

It should be understood that one or more design features of theanastomosis devices provided herein can be combined with other featuresof other anastomosis devices provided herein. In effect, hybrid designsthat combine various features from two or more of the anastomosis devicedesigns provided herein can be created, and are within the scope of thisdisclosure.

The invention of this application has been described above bothgenerically and with regard to specific embodiments. It will be apparentto those skilled in the art that various modifications and variationscan be made in the embodiments without departing from the scope of thedisclosure. Thus, it is intended that the embodiments cover themodifications and variations of this invention provided they come withinthe scope of the appended claims and their equivalents.

1.-20 (canceled)
 21. A medical device comprising: a delivery catheter;an implantable device positioned on the delivery catheter, theimplantable device including a first end, a second end opposite thefirst end, and a central portion that is selectively longitudinallycontractible and positioned between the first end and the second end; atether extending from the first end to longitudinally collapse thecentral portion; and a containing member positioned about theimplantable device configured to contain the implantable device whilethe implantable device is in a delivery configuration.
 22. The medicaldevice of claim 21, wherein the implantable device further includes acovering member positioned about the central portion.
 23. The medicaldevice of claim 21, wherein the tether is formed of one of PTFE, nylon,and combinations thereof.
 24. The medical device of claim 21, whereinthe tether is a multifilament construct.
 25. The medical device of claim24, wherein the tether includes at least one of a braided construct anda twisted construct.
 26. The medical device of claim 21, wherein thetether includes a low elasticity material.
 27. The medical device ofclaim 21, wherein the tether includes a monofilament material.
 28. Themedical device of claim 21, wherein the tether is routed through thecentral portion.
 29. The medical device of claim 21, further comprisinga locking member operable to retain the anastomosis device in alongitudinally contracted configuration.
 30. The medical device of claim21, wherein the first end includes a first apposition portion that has afirst geometry and the second end includes a second apposition portionthat has a second geometry that is different from the first geometry ofthe first apposition portion, wherein a support structure of the firstapposition portion, the second apposition portion, and the centralportion is formed of a single elongate element.
 31. A medical devicecomprising: A delivery catheter; an implantable device positioned on thedelivery catheter, the implantable device including a first elongateelement forming a first apposition portion and a central portion and asecond elongate element forming a second apposition portion, the centralportion being selectively longitudinally contractible and positionedbetween the first apposition portion and the second apposition portion,and a first tether extending from one of the first and secondappositions portion such that the first tether is tensionable tolongitudinally collapse the central portion; and a containing memberpositioned about the implantable device configured to contain theimplantable device while the implantable device is in a deliveryconfiguration.
 32. The medical device of claim 31, wherein theimplantable device further including a second tether extending fromanother of the first and second apposition portions.
 33. The medicaldevice of claim 31, wherein the implantable device further includes acovering member positioned about a central portion.
 34. The medicaldevice of claim 31, further comprising a second tether extending fromone of the first and second appositions portion such that the secondtether is tensionable to longitudinally collapse the central portion.35. The medical device of claim 33, wherein the elongate element definesa supported region at the central portion of the implantable device andthe covering member defines an unsupported region at the central portionof the implantable device.
 36. A medical device comprising: A deliverycatheter; an implantable device positioned on the delivery catheter, theimplantable device including a first elongate element forming a firstapposition portion, a second elongate element forming a secondapposition portion, and a third elongate element forming a centralportion that is selectively longitudinally contractible and positionedbetween the first apposition portion and the second apposition portion,and a first tether extending from one of the first and secondappositions portion to longitudinally collapse the central portion; anda containing member positioned about the implantable device configuredto contain the implantable device while the implantable device is in adelivery configuration.
 37. The medical device of claim 36, wherein theimplantable device further comprises a second tether coupled to anotherof the first and second apposition portions and a third tether coupledto the central portion.
 38. The medical device of claim 37, wherein thefirst, second, and third tethers are disposed at about 120° apart fromeach other around a periphery of the implantable device.
 39. The medicaldevice of claim 37, wherein the first, second, and third tethers areoperable to lock with one another to maintain a longitudinal length ofthe central portion of the implantable device.
 40. The medical device ofclaim 37, wherein each tether is operable to be trimmed to length.